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All GLG News Analyses Filed Under: Business of Medicine

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Adam Fein Posted May 1, 2008
The AMP Pharmacy Reimbursement Saga Drags On
Analysis of: NACDS, NCPA Seek to Amend AMP Lawsuit Challenging CMS' Interim Final Rule Redefining “Multiple Source Drug” | www.nacds.org
Author: Adam Fein, Founder & President Pembroke Consulting Inc
There are some new developments for Average Manufacturer Price (AMP), although the situation has now devolved into a somewhat arcane legal battle. Unless there is a legislative fix (unlikely), then I expect that Center for Medicare and Medicaid Services (CMS) will punt this issue to the next administration...
Posted May 1, 2008
FDA Provides Clarity to Isis Regarding the Development Path for Mipomersen
Analysis of: FDA Provides Clarity to Isis Regarding the Development Path for Mipomersen | www.pipelinereview.com
Author: GLG Member Program Contributor
Mipomersen (formerly known as ISIS 301012) is a in class of novel therapeutic agents that reduce the production of a protein in the liver that is responsible for cholesterol production. It is though that inhibiting that production on a molecular level would decrease the levels of cholesterol. Mipomersen...
Posted April 30, 2008
UPDATE: FDA Head Sees Economic Fraud Behind Tainted Heparin
Analysis of: UPDATE: FDA Head Sees Economic Fraud Behind Tainted Heparin | www.reuters.com
Author: GLG Member Program Contributor
First, and foremost, the only working link for this article can be found at: http://www.reuters.com/article/domesticNews/idUSWAT00934620080415?feedType=RSS&feedName=domesticNews Although there is no proof offered in the article to substantiate the suggestion of fraud, there is enough circumstantial...
Jeff Stier Posted April 30, 2008
Generic Biologics Won't Get A Free Ride
Analysis of: Don't compromise the safety of biotech drugs | www.latimes.com
Author: Jeff Stier, Associate Director American Council on Science and Health
Allowing "generic" versions of biotech drugs to market without full safety testing would endanger consumers
Posted April 30, 2008
FDA fees eyed to boost food, drug safety
Analysis of: FDA fees eyed to boost food, drug safety | www.usatoday.com
Author: GLG Member Program Contributor
One only has to read about the Heparin debacle, which has killed, at least, 81 Americans, to realize that there is a serious issue with the quality of medicines produced in China.  Manufacturing of medical food and consumer goods in China is growing at such a rate, the Chinese government has neither...
Posted April 30, 2008
The Price of Excess: Identifying Waste in Healthcare Spending
Analysis of: The Price of Excess: Identifying Waste in Healthcare Spending | blogs.wsj.com
Author: GLG Member Program Contributor
It's easy to point fingers of blame and this article does that, very well.  According to the "annalysis" everybody is to blame.  And, they're right, everyone is to blame, but where the article fails is the authoris inability to point out a real solution to the problem of wasted dollars spent...
Posted April 28, 2008
GlaxoSmithKline to acquire Sirtris Pharmaceuticals, a world leader in 'Sirtuin' research and development
Analysis of: GlaxoSmithKline to acquire Sirtris Pharmaceuticals, a world leader in 'Sirtuin' research and development | www.pipelinereview.com
Author: GLG Member Program Contributor
Situins are enzymes that regulate predetermined cell death, activity in muscle and fat cells as well as energy expenditure. There are several classes of these enzymes (SIRT 1 through 7). The technology is promising in that it promises to regulate some of the causes of diabetes and obesity rather than...
Posted April 28, 2008
The Price of Excess--Identifying Waste in Healthcare Spending
Analysis of: The Price of Excess--Identifying Waste in Healthcare Spending | www.pwc.com
Author: GLG Member Program Contributor
For the first time a major comprehensive authoritative national study (by PricewaterhouseCoopers, LLP) has concluded that over one half of the nation's $2.2 trillion in annual health spending (fully $1.2 trillion) is wasted.  Other studies have put this percentage in the 25 to 40% range. ...
Posted April 28, 2008
Glaxo Decision Moves Drug Development Forward Again
Analysis of: Federal Court Sides With GlaxoSmithKline, Strikes Down Rules Issued by Patent Office | biz.yahoo.com
Author: Louis Sanfilippo, Psychiatrist Louis Sanfilippo, MD
The USPTO’s proposed rule changes, struck down in this important Glaxo federal court decision, would have added significant burdens to pharmaceutical companies in developing their IP portfolios and ultimately their drug treatments.   The proposed changes were seemingly motivated to make the...
Mark Tapsak Posted April 24, 2008
Industry leaders need to work with the US Patent and Trademark office to keep US patents strong
Analysis of: Federal Court Sides With GlaxoSmithKline, Strikes Down Rules Issued by Patent Office | biz.yahoo.com
Author: Mark Tapsak, Assistant Professor Bloomsburg University of Pennsylvania Inc
The USPTO is facing an epidemic amount of frivolous patents.  This degrades their ability to review strong and potentially important patents in a timely manner.  Although this particular change was struck down in Federal court, industry leaders need to work with the USPTO in order...
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